Clinical Research Coordinator II - Smidt Heart Institute (Chikwe Group)
Cedars-Sinai Medical Center
Location: Los Angeles, California
Internal Number: HRC1042278
Grow your career at Cedars-Sinai!
The Smidt Heart Institute reflects Cedars-Sinai's steadfast commitment to heart disease and research innovation giving patients access to the highest level of care. Year after year, thousands of people trust their hearts to Smidt Heart Institute at Cedars-Sinai. Our cardiologists, cardiac surgeons and specialized care teams treat the full spectrum of heart disease and disorders, while our investigators continue to advance the field with groundbreaking, life-saving research. From genetic counseling and targeted drug therapies to an increasing array of minimally invasive procedures, Cedars-Sinai continues to stand at the forefront of technology, innovation and discovery improving patient outcomes.
Join our team and use your expertise with an organization known nationally for excellence in research!
Job Summary: The Clinical Research Coordinator II works independently providing study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. Responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information. Presents information at regular research staff meetings. May plan and coordinate strategies for increasing patient enrollment, improving efficiency, training of personnel, or identifying new research opportunities. Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
Primary Duties and Responsibilities •Independent study coordination including screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details to the patients, and participating in the informed consent process. • Schedules patients for research visits and procedures. •In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) the following; changes in patient condition, adverse events, concomitant medication use, protocol compliance, response to study drug. • Maintains accurate source documents related to all research procedures. • Responsible for accurate and timely data collection, documentation, entry, and reporting including timely response to sponsor queries. • Schedules and participates in monitoring and auditing activities. • Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information; present this information at regular research staff meetings. • Notifies direct supervisor about concerns regarding data quality and study conduct. • Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines. • May perform other regulatory / Institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation. •Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA and local Institutional Review Board. • Maintains research practices using Good Clinical Practice (GCP) guidelines. • Maintains strict patient confidentiality according to HIPAA regulations and applicable law. • May coordinate training and education of other personnel. • May participate in centralized activities such as auditing, Standard Operating Procedure development, etc. • May plan and coordinate strategies for increasing patient enrollment, and/or improving clinical research efficiency. • May identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality. • May identify new research opportunities and present to investigators • Participates in required training and education programs
Highschool diploma/GED required - Bachelor's degree in related field preferred
- SOCRA or ACRP certification preferred
- 2 years clinical research or related experience required
Able to perform moderate lifting. - Able to sit, stand and walk for prolonged periods of time. - Able to read papers and online documents. - Able to operate standard office equipment. - Able to exercise physical ability and perspective acuity to satisfactorily perform essential job functions.
Working Title: Clinical Research Coordinator II - Smidt Heart Institute (Chikwe Group) Department: Heart Institute Operations Business Entity: Academic / Research Job Category: Academic/Research Job Specialty: Research Studies/Clinical Trials Position Type: Full-time Shift Length: 8 hour shift Shift Type: Day
Providing healthcare for more than 100 years, Cedars-Sinai has evolved into one of the most dynamic and highly renowned medical centers in the world. Along with caring for patients, Cedars-Sinai is a hub for biomedical research and a training center for future physicians and other healthcare professionals. This attracts exceptional talent to Cedars-Sinai, including world-renowned physician-scientists who seek a place where they can both conduct research and see patients--the ideal formula for discovery and its translation into cures. Our patients benefit from access to doctors at the top of their fields, and our researchers have an ideal community in which to study the impact of healthcare challenges, and reflect that knowledge in their research. The greater Los Angeles area in which Cedars-Sinai resides possesses unparalleled cultural and ethnic diversity which offers outstanding opport...unities for translational and clinical research and a dynamic environment for medical education.Although community based, Cedars-Sinai is a major teaching hospital affiliated with the David Geffen School of Medicine at the University of California, Los Angeles (UCLA). Cedars-Sinai has highly competitive graduate medical education programs in more than 50 specialty and subspecialty areas, a graduate program in biomedical sciences and translational medicine, a clinical scholars program directed towards junior physicians with aspirations to become clinical scientists, and post graduate training opportunities.There are more than 250 full-time faculty members at Cedars-Sinai. The voluntary medical staff, comprised of more than 2,200 specialty board-certified or board-qualified physicians, represent all of the specialties and subspecialties and collaborate with full-time medical staff in the teaching responsibilities of the graduate medical education programs.